Philippine Government Updates Biotech Regulations to Speed Up Approvals

The Philippines has released its revised biotechnology regulations that aim to improve the bureaucratic process and speed up the approval of biotech products that impact food security.

The amendments in the Joint Department Circular No. 01 of 2021 by the Department of Science and Technology (DOST), Department of Agriculture (DA), Department of Environment and Natural Resources (DENR), Department of Health (DOH), and the Department of Interior and Local Government (DILG) were completed last year, after careful review of the JDC of 2016 that replaced the DA Administrative Order No. 8. One of the major changes in the new JDC is the compliance to the Republic Act No. 11032 or the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018”. Thus, the revisions include simplified requirements and procedures and shortened processing time of applications. These amendments will reduce the red tape and expedite the approval process for products of modern biotechnology.

The JDC 2021 emphasizes that products of new breeding innovations that do not contain novel combinations of genetic materials obtained through modern biotechnology are not covered by the Circular.

Section 6 of the JDC states that the Bureau of Plant Industry will serve as the frontline institution to receive and process applications for field trial, commercial propagation, and direct use.

Another new feature of the Circular is the formation of a Joint Assessment Group (JAG) composed of qualified representatives or personnel from the Biosafety Committees and external technical experts. The JAG will be in charge of evaluating whether the regulated article does not pose greater risks to human health and the environment than its conventional counterpart. The Group, which will also include External Technical Experts from DOST, DA, DENR, and DOH will then make recommendations to the BPI Director.

Information on socio-economic, cultural, and ethical consideration may be submitted by the public during the public consultation process and this will be considered by the BPI Director, together with the technical evaluation on the safety of the product by the Joint Assessment Group, in the approval. For the field trial, a contingency plan in case of force majeure or intrusions in the field trial site has been added in the supporting documents required.

The period for public comments has been reduced from 60 days to 15 working days since the publication of the public information sheet on one newspaper of general circulation.

The JDC also indicated that regulation of stacked plants developed through conventional breeding of GM parental lines with approved individual events is not considered novel. Thus, the permit holder may request listing of their stacked events in the BPI Approval Registry for commercial propagation of direct use.

The Circular was published on March 8, 2022, in Daily Tribune and Malaya Business Insights and will be in effect 15 days thereafter.

Download a copy of the Circular from the BPI website.